FDA Inspection
Foresight Imaging, LLCForesight Imaging, LLC – FDA Inspection, Aug 29, 2017
Record Details
This FDA Inspection record concerns Foresight Imaging, LLC, with an inspection on August 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 20363830-40ca-41d7-af38-88e96408b2eb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1023886
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.86Acceptance status
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Foresight Imaging, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2025 | NAI | New England District Office | Postmarket Assurance: Medical Devices |
| December 20, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 12, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 20, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Foresight Imaging, LLC
- FDA Inspection 1294938 - 2025-12-12
- FDA Inspection 1194465 - 2022-12-20
- FDA Inspection 810782 - 2012-12-12
- FDA Inspection 658431 - 2010-04-20
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.